Partha Roy, Ph.D.

Partha Roy, Ph.D.

Partha Roy, Ph.D.

Vice President, Technical

Partha draws on over 19 years of drug development experience that includes core training in translational sciences in academia followed by R&D experience in brand and generic pharma companies, US FDA clinical pharmacology review experience, and regulatory consulting experience in a global CRO. Partha currently leads the North American Clinical Strategy Team, responsible for providing strategic technical guidance on various clinical and regulatory aspects of drug and device development.

He helps multiple clients mapping out regulatory strategies for drug and drug-device combination candidates ranging from pre-IND to NDA/BLA stages in multiple therapeutic areas. 

Work Experience

Prior to joining Parexel, Partha worked at the FDA, supporting the Division of Pulmonary, Allergy and Rheumatology (DPARP) as part of the clinical pharmacology review team. His other experience includes working with novel Biologics, Biosimilars, Small Molecules, Orally inhaled and transdermal products, OTC medications, and Combination Products. Partha also has extensive FDA review experience with 505(b)(2) pathway, BA/BE, dose selection, PK and PK/PD, biomarkers, clinical trial design, DDI, special populations and pediatric plans.

Education

Partha holds a B.S. in Pharmacy from Jadavpur University, Kolkata, India and a PhD in Biochemical Toxicology from the University of South Florida, and has completed a postdoctoral training in Drug Metabolism and Pharmacokinetics involving cancer chemotherapy at Boston University.

We are always available for a conversation.

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